Posted by Michael Wonder on 05 Jan 2023
Sedana Medical receives FDA fast track designation in the US
4 January 2023 - Sedana Medical today announces that the US FDA has granted fast track designation for the evaluation of isoflurane via the Sedaconda ACD-S device for sedation of mechanically ventilated patients in the intensive care setting.
Sedana Medical is aiming for a combination registration of the medical device Sedaconda ACD and the pharmaceutical isoflurane for sedation of mechanically ventilated intensive care patients in the US. Two identical Phase 3 studies, INSPiRE-ICU 1 and 2, are on-going with the objective to confirm the efficacy and safety of inhaled sedation with isoflurane delivered via Sedaconda ACD in intensive care.
